Latest news with #BioPharmaDive
Yahoo
10 hours ago
- Health
- Yahoo
Vinay Prasad, in surprise reversal, to rejoin FDA after abrupt departure
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Vinay Prasad will return to lead the Food and Drug Administration office that oversees vaccines and gene therapy in a stunning reversal that comes less than two weeks after he abruptly left the job. Andrew Nixon, a spokesperson for the Department of Health and Human Services, confirmed Prasad's return in an emailed statement Saturday. 'At the FDA's request, Dr. Vinay Prasad is resuming leadership of the Center of Biologics Evaluation and Research,' Nixon wrote. The news was reported earlier by Endpoints News and Stat news. Prasad's return marks the latest dramatic twist in what's already been a tumultuous run leading CBER, which in addition to vaccines and some genetic medicines also reviews blood products. Prasad was appointed by Commissioner Martin Makary to run CBER on May 6. A longtime critic of U.S. drug policies and prolific academic, he was described by Makary as bringing the 'scientific rigor, independence and transparency' the office needed. Makary later named Prasad as the FDA's chief medical and scientific officer, in addition to his role at CBER. Prasad was skeptical of his predecessor Peter Marks, who led CBER for almost a decade before leaving in March following a dispute with HHS Secretary Robert F. Kennedy, Jr. Marks had overseen the review and approvals of COVID-19 vaccines as well as dozens of cell and gene therapies and, in doing so, had championed regulatory flexibility. Prasad condemned many of those decisions and, notably, castigated Marks for overruling other FDA staffers in clearing Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy Elevidys. After joining the FDA, Prasad worked with Makary to establish stricter approval guidelines for COVID-19 vaccines and three times stepped in to override fellow agency reviewers in issuing slimmer-than-requested clearances for shots developed by Moderna and Novavax. Prasad also attempted to ease concerns that CBER might be less flexible with him involved. But in July, the FDA rejected a Duchenne cell therapy from Capricor Therapeutics that Prasad reportedly scrutinized. Shortly thereafter, the agency got into an unusual public spat with Sarepta over Elevidys, during which the company on July 21 temporarily stopped shipping the therapy at the agency's request. Published reports had indicated that the company might need new safety data before the FDA would allow Elevidys back on the market. But in the following days, Prasad's decisionmaking and political views were targeted by right-wing influencer Laura Loomer, other conservative commentators and op-eds published in the Wall Street Journal. The FDA then allowed Elevidys shipments to resume on July 28, and Prasad resigned a day later, with the HHS at the time saying he 'did not want to be a distraction' to the FDA and wanted 'to be with his family.' Analysts had speculated that Prasad's sudden departure might mean that political forces and patient pressure could be playing a larger role in agency decisionmaking than in the past. A published report from Politico also suggested Trump himself directed Prasad's firing over the opposition of Makary and Kennedy. Makary has since publicly campaigned for Prasad to return. Upon news of his rehiring Saturday, Loomer posted on the social media platform X that she'd be 'ramping up my exposes of officials within HHS and FDA' in the coming weeks 'so the American people can see more of the pay for play rot themselves and how rabid Trump haters continue to be hired in the Trump administration.' George Tidmarsh, who in July was named the head of the FDA's other primary drug review office, has been serving as CBER's acting director over the last week or so. Recommended Reading FDA follows EMA in limiting use of Valneva shot
Yahoo
3 days ago
- Business
- Yahoo
Iovance cuts staff amid slow sales start for ‘TIL' cell therapy
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Iovance Biotherapeutics will lay off staff in a restructuring that follows a significant cut to its revenue forecasts earlier this year. A spokesperson on Thursday confirmed Iovance's plans to reduce its workforce by 'less than 20%.' A regulatory filing showed Iovance employed 838 people at the end of last year, though a company presentation last month indicated that number had grown to more than 1,000. Iovance's workforce will still have more than 1,000 people following the job cuts, which will affect full-time employees as well as contractors, according to the spokesperson. 'After careful evaluation of our long-term goals, operational needs, and resources, we have implemented a strategic restructuring that includes a selective reduction in force to support our mission to innovate, develop and deliver TIL cell therapy to patients in need,' the spokesperson wrote in an email, referring to the type of cellular medicine Iovance specializes in. 'This restructuring will extend our cash runway, and we remain on track to deliver on our financial goals.' In a second quarter earnings report Thursday afternoon, the company said that 19% of its workforce would be impacted by the cuts. The restructuring will save Iovance more than $100 million annually and enable it to operate through the fourth quarter of 2026. Iovance will also 'continue to optimize and refine its cost structure' through what it described as 'operational excellence initiatives' over the next few quarters, it said in a statement. Iovance had about $307 million in cash on hand at the end of June. The layoffs come after a slow commercial start for Amtagvi, a cell therapy Iovance developed for an advanced form of skin cancer. Amtagvi is the first marketed cellular medicine made by engineering human cells known as tumor-infiltrating lymphocytes, or 'TILs.' The therapy originated from research at the National Institutes of Health in the 1980s and got to market only after decades of fine-tuning, as well as multiple regulatory delays. Amtagvi was cleared in February 2024 for people whose melanoma progressed after a commonly used immunotherapy or targeted cancer medication. It's derived from a patient's tumor tissue in a complex, weekslong manufacturing process. Upon approval, analysts and investors were skeptical of its sales potential, given questions about demand and the complex logistics involved. At about $515,000, the drug's list price was also at the time the highest of any cell-based medicine for cancer in the U.S. Iovance initially projected product revenue — which includes contributions from a different immunotherapy called Proleukin — would reach $450 million to $475 million this year. But in May, it cut that forecast by 40%, to between $250 million to $300 million, citing 'recent launch dynamics' that had changed its view. In a research note last month, Mizuho Securities analyst Salim Syed noted how prior guidance was modeled on launches from other marketed cancer cell therapies known as CAR-T treatments, whereas the updated projections rely on 'real data' from centers actively administering Amtagvi. Iovance said in its latest earnings report that 102 patients were treated with Amtagvi in the second quarter, equating to about $54 million in sales. Shares fell about 30% as the numbers 'were on the lighter side' of the 100 to 110 patients Iovance had anticipated treating, and total product revenue of $60 million missed consensus estimates, wrote Syed in a note to clients Thursday. Amtagvi could be approved in Europe, the U.K. and Canada this year. It's also in late-stage testing for non-small cell lung cancer. Iovance shares have lost most of their value over the last 12 months. Editor's note: This story has been updated to include details from Iovance's earnings report. Recommended Reading Treeline Bio deepens investor roots with fresh funding for cancer drug research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
4 days ago
- Business
- Yahoo
Strand raises another $153M to make ‘programmable' mRNA drugs
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Strand Therapeutics has raised a $153 million Series B round fresh off unveiling early, but promising results for a cancer therapy it's making with messenger RNA technology. The biotechnology startup plans to use the funding to advance that therapy, STX-001, into further testing. A second, experimental medicine called STX-003 should start a Phase 1 clinical trial next year, said Jake Becraft, Strand's CEO and co-founder. Strand is making what it describes as 'programmable' mRNA therapies that are meant to express proteins in a targeted and timely fashion. Its lead therapy contains the genetic instructions for IL-12, a cytokine that's been well-studied by drugmakers as a potential booster to cancer immunotherapies, but with mixed results. Rather than administering a recombinant version of the protein, though, Strand uses an mRNA construct to get into tumor cells so they express IL-12, making them more visible to the immune system. The result is supposed to be a precise and powerful cancer-killing blow. Data presented at the American Society of Clinical Oncology meeting earlier this year offered a glimpse at the approach's promise. In a small, early-stage study, treatment with STX-001 was associated with multiple responses, including one complete response, in people whose solid tumors hadn't responded to widely used 'checkpoint inhibitor' cancer immunotherapies. The result 'underpins what a genetic modality like messenger RNA can offer in this setting,' Becraft said. That study is ongoing and testing STX-001 as a monotherapy or alongside Merck & Co.'s checkpoint inhibitor Keytruda against multiple tumor types. Strand's Series B round was led by Kinnevik, a European venture capital firm that's invested in biotechs like Recursion Pharmaceuticals and Enveda Biosciences. A dozen other investors also participated, among them Regeneron Ventures, Amgen Ventures and Eli Lilly, and the family office of former Johnson & Johnson CEO Alex Gorsky. Before this year's raise, Strand had banked $97 million to fund its research. The company was launched in 2017 by Becraft and co-founder Tasuku Kitada, years before mRNA technology played a starring role in ending the COVID-19 pandemic. The latest financing comes as mRNA vaccines have become a political target. Earlier this week, the U.S. Department of Health and Human Services canceled nearly $500 million in research funding for mRNA vaccine research. Strand, though, is using mRNA to make therapeutics instead of vaccines, and Becraft contended the technology's 'future is incredibly bright.' Strand has five other programs in development. Among them are STX-003, which is targeting non-small cell lung cancer and other tumors, and a pair of programs aimed at blood malignancies. Strand also hopes to eventually prove it can deliver its drugs to a variety of organs and tissues, a difficult hurdle for many developers of genetic medicines to overcome. 'We're interested in anywhere we can create new medicines or innovate on massive limitations of existing medicines,' Becraft said.
Yahoo
5 days ago
- Health
- Yahoo
Pharma prepared to work with Trump on DTC drug sales: Pfizer CEO
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Pfizer and other large pharmaceutical companies are taking seriously President Donald Trump's demand that drugmakers make more of their medicines available direct to consumers in the U.S. at lower cost, Pfizer CEO Albert Bourla said Tuesday. 'We have serious discussions in the industry,' Bourla told investors on a conference call Pfizer held to discuss its earnings for the second quarter. 'I'm connected very often individually with all the major companies and they are all ready to roll up their sleeves and execute something like that.' Pfizer and partner Bristol Myers Squibb recently announced plans to offer their widely-used blood thinner Eliquis at a discounted cash price through an online service. The company previously launched a direct-to-consumer service that allows patients to book telehealth appointments, schedule vaccinations and fill prescriptions for certain medicines, such as those Pfizer sells for migraine and COVID-19. 'We think it is a fantastic way to go ahead, so we will work collaboratively to do it,' Bourla said. Obesity drugmakers Eli Lilly and Novo Nordisk have also recently opened up more ways for cash-paying patients to access their weight loss medicines directly. Other companies are signaling interest, too, in exploring ways to sidestep pharmacy benefit managers. These drug-purchasing middlemen extract from drugmakers rebates that insurers say they use to lower overall costs, but not necessarily in ways that are obvious to a prescription-filling patient. Expanding direct-to-consumer options was one of four demands Trump made of the pharmaceutical industry last week in letters issued to 17 drugmakers, including Pfizer. In those letters, the president threatened to use 'every tool' the U.S. government has available if the companies don't take steps to lower the cost of their products to the prices paid in other industrialized countries. Such a 'most favored nation' policy could be a major blow to the industry, although analysts are divided on how sweeping its impact would be if limited only to Medicaid, as Trump indicated. On Tuesday's call, Bourla said he is in 'active discussions' at the 'highest levels of the U.S. government,' including conversations with Trump, Health and Human Services Secretary Robert F. Kennedy Jr., and Centers for Medicare and Medicaid Services Administrator Mehmet Oz. In addition to leading Pfizer, Bourla is the current board chair of industry lobbying group PhRMA. 'The letter asks a lot from us,' Bourla added. 'But we are engaged in productive discussion with them and in general I'm happy with the way that they listen to us.' Pricing threats aren't the only challenge drugmakers face in the U.S. The Commerce Department is nearing the end of an investigation into pharmaceutical imports expected to result in sector-specific tariffs. On Tuesday, Trump told CNBC that his administration will initially impose a small levy on pharmaceuticals that could later rise as high as 250% over time. Such duties would be costly for drugmakers, but analysts believe a phase-in period would allow many companies to adjust their supply chains in such a way that the worst financial hit could be mitigated. Already, most of the largest drugmakers have announced major manufacturing investments in the U.S. Pfizer anticipates that it can absorb the impact of tariffs this year, as well as any changes it makes to its products' prices, while still meeting its financial forecast of $61 billion to $64 billion in revenue. On Tuesday, the company raised its guidance for adjusted diluted earnings per share by 10 cents. Shares in Pfizer rose by nearly 4% by midday Tuesday. Recommended Reading Trump redoubles threats in attempt to strongarm drugmakers on prices Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
31-07-2025
- Business
- Yahoo
Moderna to lay of 10% of workforce in ‘difficult but necessary step'
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Moderna said Thursday it plans to lay off 10% of its workforce, or more than 800 employees, as part of an ongoing effort to cut expenses amid slowing vaccine sales. Moderna first announced last September a plan to lower $1.5 billion in annual operating expenses by 2027, largely by trimming research spending. The company planned to hit that mark without cutting into its workforce, with a spokesperson at the time calling the restructuring a 'financial change' that wouldn't involve layoffs. In a Thursday memo to employees, CEO Stéphane Bancel wrote that the company has made 'significant progress' towards that goal, in part by renegotiating supply deals and lowering manufacturing costs. But while 'every effort was made to avoid affecting jobs,' the company now has to reduce its headcount, too. Bancel didn't detail which types of roles will be affected, but revealed the company's global workforce — which totaled more than 5,800 people in 18 countries at the end of last year — will be cut to less than 5,000. "Reshaping our operating structure and aligning our cost structure to the realities of our business are essential to remain focused and financially disciplined, while continuing to invest in our science on the path to 2027,' Bancel wrote. Moderna rose to stardom during the COVID-19 pandemic, bringing one of the first coronavirus shots to market and earning billions of dollars in product sales as a result. But its financial fortunes have reversed since then due to declining demand for COVID-19 shots and slow uptake for an RSV vaccine it's also brought to market. Moderna has revised its revenue guidance multiple times amid the slowdown, too, eroding confidence in its management team and leading analysts to long expect expense cuts and layoffs. The job cuts announced Thursday are 'necessary to right-size the company's operational footprint to offset continued vaccine revenue decline,' Leerink Partners analyst Mani Foroohar wrote in a note to clients. The change in U.S. public health leadership this year has hurt Moderna, too. The Food and Drug Administration has implemented a stricter approval framework for COVID shots that's resulted in narrower-than-expected clearances. Health and Human Services Secretary Robert F. Kennedy Jr. has also recast an influential vaccine committee with some members skeptical of the messenger RNA shots Moderna is known for. HHS terminated a contract with Moderna to develop mRNA vaccines for bird flu as well. Moderna is counting on newer shots it's developing — among them a cancer vaccine being co-developed with Merck & Co. and a combination COVID and influenza vaccine — to help change its outlook. 'Our mission remains unchanged. With three approved products and the potential for up to eight more approvals in the next three years, the future of Moderna is bright. We are sharpening our focus, becoming leaner, and staying ambitious in oncology, rare diseases and latent viruses,' Bancel said in the memo. Moderna will report its latest quarterly results on Friday. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
